Lecrolyn sine

Medicinal product

(Invented) name

Lecrolyn sine

Active substance (s)

Natrio kromoglikatas

Strength

40 mg/ml

Pharmaceutical form

akių lašai (tirpalas)

Route (s) of administration

vartoti ant akių

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01GX01, Cromoglicic acid

Marketing authorisation holder

Santen Oy, Suomija

Date of authorisation

2015-04-22

Date of renewal

2021-05-24

Documents

3711_pakuotes lapelis_2021-05-24.docx

3711_Lecrolyn_sine_tirp_perr2021-05-24.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/1402/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename ml tirpalo yra:	1 ml
Natrio kromoglikatas	40 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
58610	72793	1072793	buteliukas	5 ml N1		Nereceptinis	LT/1/15/3711/001	Netiekiama	-	-	No	-	-
61906	76277	1076277	buteliukas	5 ml N2		Nereceptinis	LT/1/15/3711/002	Netiekiama	-	-	No	-	-
61907	76278	1076278	buteliukas	5 ml N3		Nereceptinis	LT/1/15/3711/003	Netiekiama	-	-	No	-	-
67204	81748	1081748	buteliukas	10 ml N1		Nereceptinis	LT/1/15/3711/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-05-24	Perregistruotas
2015-04-22	Registruotas